The Impact of Daily Sinus Irrigation on Nasal Symptoms in Continuous Positive Airway Pressure (CPAP) Users - A Pilot Study

NCT01121445 | Unknown

• 1 other identifier: IRB #041001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous positive airway pressure (CPAP) is the most commonly used treatment for obstructive sleep apnea. Nasal symptoms such as dryness, itching and congestion are common in CPAP users. Nasal and sinus saline irrigation has been shown to improve these symptoms in individuals with chronic nasal congestion and sinusitis. This is an 8 week study that investigates whether daily saline nasal and sinus irrigation reduces nasal symptoms in patients using CPAP, improves quality of life and CPAP compliance.

Conditions

Obstructive Sleep Apnea

Keywords

Sleep apnea; CPAP; Saline irrigation

Outcome Measures

Primary Outcomes (1)

• RQLQ (Rhinoconjunctivitis Quality of Life Questionnaire)

  A 28-item, self administered questionnaire measuring nasal symptoms and other domains, including activity limitations and eye symptoms. Subjects will be asked to rate their symptoms on a 7-point scale (0=no impairment, 6=severely impaired). Change in RQLQ with daily saline irrigation in CPAP users is the primary outcome of interest.

  4 weeks

Secondary Outcomes (3)

• Epworth Sleepiness Scale

  4 weeks

• SF-36

  4 weeks

• CPAP compliance

  4 weeks

Study Arms (1)

CPAP with heated humidification

NO INTERVENTION

Standard of care

Device: NeilMed nose and sinus irrigation

Interventions

NeilMed nose and sinus irrigation DEVICE

Saline irrigation used daily plus CPAP with heated humidification for 4 weeks

CPAP with heated humidification

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Apnea/hypopnea index ≥ 10
• A documented successful CPAP titration

You may not qualify if:

• Conditions that in the judgment of the investigator would interfere with subject participation in the study
• History of sinus or nasal surgery
• History of psychiatric illness
• Use of sleep aids, sedatives or narcotics
• Use of oral of subcutaneous anti-coagulants (i.e. warfarin, enoxaparin)
• Bilevel or other nocturnal ventilation other than CPAP
• Use of supplemental oxygen
• Pregnancy or lactating
• Inability or unwillingness to provide informed consent
• Inability to perform baseline measurements
• Inability to be contacted by phone

Sponsors & Collaborators

• Bridgeport Hospital: lead
• NeilMed Pharmaceuticals: collaborator

Study Sites (1)

Bridgeport Hospital

Bridgeport, Connecticut, 06610, United States

RECRUITING

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Jeff S Kwon, MD

  Bridgeport Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 6, 2010
• First Posted: May 12, 2010
• Study Start: May 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: May 12, 2010

Record last verified: 2010-05

Locations

US (1)